Clinical trial · Interventional
Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions
Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomised Clinical Trial
NCT03684707CI-TRIAL-00035045unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the metformin drug effect as a drug that found to improve the quality of tissues, decrease signs \& symptoms of cancer, and decrease histo-pathological criteria of dysplasia. This will be done by the aid of measuring salivary Micro RNA 31 \& 210 in saliva in addition to measure cyclin A2 as an immuno-histochemical analysis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hcl 500Mg 24Hr Sa Tab | Drug | — | UNRESOLVED |
| starch tablet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin Hcl 500Mg 24Hr Sa Tab
- description
- Metformin Hcl 500Mg 24Hr Sa Tab drug is given to the patient
- interventionNames
- Drug: Metformin Hcl 500Mg 24Hr Sa Tab
- type
- PLACEBO_COMPARATOR
- label
- control
- description
- starch tablets
- interventionNames
- Other: starch tablet
Primary outcomes (1)
- measure
- Evaluate lesion size in millimeters
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Both genders with age range from 20 to 70 years. * Patients able to return for the follow up visits and can perform oral hygiene measures. * Clinically diagnosed and histologically confirmed as having oral potentially malignant lesions. * Patients agreed to sign a written consent after understanding the nature of the study * Patients have diagnosed oral premalignant lesion/lesions and not yet turned into malignancy (atrophic lichen planus- leukoplakia-erythroplakia - oral submucous fibrosis) Exclusion Criteria: * \- Diabetic patients (Diabetes Mellitus Type I \& II) * Patients have cardiovascular, lung, Renal, Liver diseases * Patients on H2 blocker \& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance) * Those with allergy or sensitivity to Metformin or Retinoids therapy or having any contraindication for their use. * Systemic and/or local systemic drug therapy within the last 3 months prior to the start of the study * Patients on steroidal or Non-steroidal anti-inflammatory drugs (NSAIDs) for at least the last 6 months * Patients on Antibiotics treatment for at least the last 2 months * Patients on Retinoid, green tea supplements or another natural products therapy * Patients with already diagnosed malignant lesion/lesions * Pregnant or Lactating females * Vulnerable groups as prisoners, mentally disabled, etc…
References
Publications (0)
Data not yet available
No reference posted for this study.